Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 66 of 138
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2571-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070", REF SA6JL60SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2696-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2752-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2616-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2738-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2575-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75 SH, .070", REF SA6EBU375SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2668-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2683-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2715-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2682-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2599-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.0 SH, .070", REF SA6EBU30SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2666-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2565-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2619-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2641-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2710-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB, .070", REF SA6RCB. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2645-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2708-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2617-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2706-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2624-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2592-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5 SH, .070", REF SA6SAL15SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2709-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2614-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2639-2019 October 9, 2019 Danvers, MA